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Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor: The First Affiliated Hospital of Bengbu Medical University
Summary
This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .
Official title: Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma: a Single-center, Prospective, Single-arm Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-03-30
Completion Date
2026-12-30
Last Updated
2024-03-07
Healthy Volunteers
No
Conditions
Interventions
Recombinant Human Adenovirus Type 5
Recombinant Human Adenovirus Type 5( H101 )was administered intratumorally on day 1 and 5 of cycle 1 and cycle 2. If the sum of the maximum diameters of the lesions was less than or equal to 10 cm, the total dose was 1.0×10\^12 vp . If the sum of the maximum diameters of the lesions was more than 10 cm, the total dose was 1.5×10\^12 vp. Recombinant Human Adenovirus Type 5 was diluted to 30% of the total tumor volume with normal saline before administration. Under the guidance of ultrasound, percutaneous puncture was performed to the center of the tumor, and the solution was uniformly injected into the tumor. If there are multiple lesions, the distribution of each lesion should be proportional to the size of the tumor. No more than 5 lesions.
Lenvatinib
Lenvatinib was administered orally once daily started on day 1 of cycle 1 of the study until disease progression or unacceptable toxicity occurred or meet the end point of the study. For patients weighing less than 60 kg, the recommended daily dose was 8 mg once daily. For patients weighing ≥60 kg, the recommended daily dose was 12 mg once daily
Tislelizumab
Tislelizumab 200mg was administered intravenously every 3 week started on day 1 of cycle 3 until disease progression or unacceptable toxicity occurred or meet the end point of the study.